MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS II HUMERAL HEAD 56/22; PROSTHESIS, SHOULDER, CEMENTED

Model Number	UNIVERS II HUMERAL HEAD 56/22
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body Reaction (1868)
Date of Event	11/04/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 11/07/2024, it was reported by a sales representative via phone that a patient had a shoulder scope arthroplasty procedure completed successfully three years ago.The patient reported having post-surgery adverse reactions to the implant that was implanted.The surgeon performed a biopsy and found metallosis in the joint.Photos were taken of the issue.Additional information was received on 11/08/2024 via email: on 11/04/2024, the surgeon brought one of his patients back to the operating room for a biopsy and diagnostic arthroplasty to see why, after a successful tsa outcome, the patient had suddenly experienced a high amount of pain in the last 6 months.Shots and conservative treatments failed, and the patient was brought into the or for arthroscopic evaluation.The surgeon found severe metallosis in the joint (photo attached).No failure of implants or looseness could not be determined at the time.The surgeon took the arthroscopic biological cultures and sent them to the lab for analysis.The arthrex products implanted in the initial surgery were ar-9106-03 arthrex univers vaultlock glenoid, ar-9100-11s univers apex humeral stem, and ar-9156-22p arthrex univers ii 3d humeral head.The initial surgery was done on 11/14/2021 at the same location as the diagnostic scope.Additional information has been requested.
Event or Problem Description
Additional information was received on 11/22/2024 via email: the reaction was localized in the shoulder joint, and no revision has been scheduled yet.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Based on visual inspection and analysis the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to a patient-specific event.

• Brand Name: UNIVERS II HUMERAL HEAD 56/22
• Common Device Name: PROSTHESIS, SHOULDER, CEMENTED
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 20854169
• Report Number: 1220246-2024-08711
• Device Sequence Number: 20988229
• Product Code: KWS
• UDI-Device Identifier: 00888867136595
• UDI-Public: (01)00888867136595(11)191223(17)241130(10)10525390
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K071032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/22/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2024
• Device Model Number: UNIVERS II HUMERAL HEAD 56/22
• Device Catalogue Number: AR-9156-22P
• Device Lot Number: 10525390
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2024
• Supplement Date Received by Manufacturer: 11/22/2024; 08/20/2025
• Initial Report FDA Received Date: 12/05/2024
• Supplement Report FDA Received Date: 12/20/2024; 08/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/23/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown